By Douglas S. Kalman MS, RD, CCRC, FACN
It is often argued that once an ingredient has been marketed to the public within the confines of the 1994 Dietary Supplement Health Education Act (DSHEA 1994), that there is no reason to conduct any research on the ingredient.
It should be understood that the DSHEA law essentially grandfathered any dietary supplement that was sold pre-November of 1994 as âapprovedâ to be sold, once the DSHEA law was enacted. Within the confines of DSHEA, the law also stated that if an ingredient had not been offered for sale (Sold) pre-November 1994, than the person or entity that wished to sell it must submit either a New Dietary Ingredient submission (NDI) or file the proof that the ingredient is commonly eaten in the American diet in similar quantities that the supplement would provide. As one might imagine, many companies may be unaware of the NDI provision or may choose to actually ignore it. In addition, some may also firmly believe that the ingredient they wish to retain is in the food supply, so the ingredient needs no formal filing (not true).
Clinical research studies can be used to accumulate safety data (animal and/or human) and this data can be used as part of the portfolio in the NDI submission. In addition, the accumulation of safety data is useful for your Intellectual Property Portfolio (IP). Probably what is more important from the view of avoiding litigation is having substantiation data to support marketing claims for your product. Substantiation does come directly from first-hand clinical trials (the efficacy part of the study). I am sure that it has not gone unnoticed by the majority of supplement firms that the Federal Trade Commission (FTC) has been very active prosecuting those who they believe have made untruthful or unsubstantiated claims. In fact, one firm recently settled a 10-million dollar consent order, while yet another paid $400,000 to the FTC for making marketing claims without having any true data to back up their internet, newspaper, radio and other marketing. Science, supporting science, is not limited to âthird-partyâ data, but now has to be and should be direct data from clinical trials that you have sponsored on your product.
As an aside, many companies appear to âborrow scienceâ â meaning that they utilize published studies on the ingredients that are within their products as âproofâ that their products are scientifically valid. This line of thought is a slippery slope. It appears that the FTC and now the FDA (by default) say that third-party published studies (borrowed science) is only legitimate if the product has the same exact ingredient and the same exact dose as what was published. However, there is not direct discussion of how to deal with multi-ingredient products. In short, borrowed science by itself appears to be a weak defense of safety and or efficacy of any multi-ingredient product.
In addition to the FTC, there is the plaintiffâs bar that companies should be wary of. Successful lawsuits have been brought around the country (but concentrated in California) against various dietary supplement firms for false advertising. The majority of these false advertising cases have centered on what the plaintiffâs believed to be the lack of any real clinical trial data to support the marketing claims. The end result - many of the cases have been won and companies have filed for bankruptcy. It may be said that some of these companies were short sighted in that they believed that they did not need any first hand direct evidence (data from clinical trials) to support their claims (or in the converse, to be the basis for their marketing). This line of thought is a mistake. Clinical trials, properly designed studies, can have the average price tag of one or two pages of advertising in a medium sized magazine â whereas if you have no real data to support your claims, you run the risk of having the price tag equal to the cost of shutting down your company. Is that worth the short-term gain?